GXPeople are looking for a QMS Engineer to join a well-established Medical Device manufacturer to join their Quality team.
The Quality Management System (QMS) Engineer takes full ownership of the areas of Quality Management System. The role supports the rest of the QA/RA team and wider business with issues related to overall quality assurance, control and compliance.
Support quality driven technology driven projects.
Compliance to ISO 13485:2016 and/ or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements
Usage of Quality Investigational tools
Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.
Continuously improving processes to promote more agile workflows
Conduct gap analysis for standards and regulations
Provide QMS Induction training for new starters
Contribute to product Risk Assessment
Co-host Notified Body, regulatory authority and customer audits (with QSM/SRAO)
Experience in providing Quality Assurance support for New Product Development, Implementation and Launch
Training of cross functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP and others
Support device testing activities (IEC 60601-1, 60601-1-2 etc)
Experience and working knowledge of Quality Assurance
Experience in Medical Device Manufacturing
Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.
Working knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC) and Medical Devices Regulations (EU) MDR 2017/745
Knowledge of IEC 60601 standards, particularly 60601-1 (Electrical Safety), 60601-1-2 (EMC) and 60601-1-6 (Usability)
Experience with Risk Management to ISO 14971